Patients with T2T3 low rectal cancer (size =< 4 cm) received neoadjuvant treatment (50Gy in 5 weeks with concomitant chemotherapy. Good responders (residual tumour =< 2 cm) are randomised in local vs rectal excision, 6-8 weeks after treatment. The composite end point evaluates the rate of patients with death, recurrence, major morbidity or severe after effects at two years.

Compare the proportion of patients presenting at least 1 component of the composite outcome (4 components: death, recurrence, major morbidity and severe after effects) at 2 years after [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Compare the incidence at 2 years of each component separately: death, recurrence, major morbidity and severe after effect [ Time Frame: 24 months ] [ Designated as safety issue: No ]

New surgical option in good responders after neoadjuvant treatment for low rectal cancer

Procedure: local rectal excision

New surgical option in good responders after neoadjuvant treatment for low rectal cancer

Active Comparator: 2

Standard surgery

Procedure: total mesorectal excision

standard surgery

Detailed Description:

Rectal excision is the standard surgical treatment of rectal cancer. The risk of mortality and major short and long term morbidity induced by rectal excision justifies new treatments. Local excision is a conservative alternative approach associated with low mortality and morbidity. The purpose of this prospective randomised multicenter study is to compare local vs rectal excision in good responders after radiochemotherapy for low rectal cancer.

Patients with T2T3 low rectal cancer, less than 8 cm from the anal verge, size =< 4 cm, received neoadjuvant treatment, included radiotherapy between 45-55Gy in 5 weeks with concomitant chemotherapy consist of at least, one fluoropyrimidine.

Good clinical responders (residual tumour =< 2 cm) are randomised in local vs rectal excision, 6-8 weeks after treatment. In case of not confirmed pathological response following local excision, complementary rectal excision is required.

Bad responders (residual tumour > 2cm) are treated by primary rectal excision. Follow-up includes digital rectal examination, CT-scan and endorectal ultrasound (if local excision) every 4 months for 2 years, then every 6 months for 3 years.

Contra indication for radiotherapy and/or fluoropyrimidine use in chemotherapy

History of cancer

Symptomatic cardiac or coronary insufficiency

Severe renal insufficiency

Peripheral neuropathy

Patient included in a trial

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Please refer to this study by its ClinicalTrials.gov identifier: NCT00427375